Quality Control Chemist

About This Role

This Quality Control Chemist supports method transfer and validation for assigned programs, authors and reviews protocols and reports, and collaborates with internal and external testing sites in a regulated biotechnology or pharmaceutical environment.

Responsibilities

• Support Project Lead for method transfer and/or validation internally and externally for assigned program(s)
• Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods
• Plan and track method transfer and/or method validation deliverables
• Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional reps
• Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis
• Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals

Requirements

• Bachelor’s degree in life science (analytical chemistry, biology, biochemistry, pharmaceutical science or related technical discipline)
• 8-10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry, and/or QC in a regulated biotechnology or pharmaceutical company
• Expertise in designing and evaluating method validation and transfer studies
• Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports
• Expert knowledge of scientific principles and expertise of mAb, Client, vaccine, gene therapy

Qualifications

• Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any related technical discipline
• 8-10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility

Nice to Have

• Post-graduate degree in a related field
• Experience with analytical separation methods (SEC, icIEF, CE-SDS)

Skills

* Required skills